Version 5 2020-06-12 Manufacturer Product Catalogue number Product Name (IVD product) Reference detail Manufacturer Detection type Anticipated Shelf life (months) Recommended storage temperature Specimen type Comments Eligibility criteria+L29 QIAamp Viral RNA Mini Kit RNA mini kit (QIAgen) Light Cycler 480 (Roche) Rotor-Gene Q 5plex HRM (Qiagen) Applied Biosystems Quantstudio5 (Thermo Fisher Scientific) Applied Biosystems 7500 Real-Time PCR Instrument system (Thermo Fisher Scientific) CFX96™ Real-Time PCR Detection system (BIO-RAD) For consumables and details of componants refer to IFU US FDA EUA Health Canada/Interim Order 444213 1COPY COVID-19 QPCR KIT 1DROP INC. (imported by Luminarie Canada Inc.) E gene and RdRp gene 100T/kit see IFU lower than -20 ºC see IFU List of SARS-CoV-2 Diagnostic test kits and equipments eligible for procurement according to Board Decision on Additional Support for Country Responses to COVID-19 (GF/B42/EDP11) SARS-CoV-2 Nuclear Acid Amplification Technologies The following emergency procedures established by WHO and the Regulatory Authorities of the Founding Members of the GHTF have been identified by the QA Team and will be used to determine eligibility for procurement of COVID-19 diagnostics. The product, to be considered as eligible for procurement with GF resources, shall be listed in one of the below mentioned lists: - WHO Prequalification decisions made as per the Emergency Use Listing (EUL) procedure opened to candidate in vitro diagnostics (IVDs) to detect SARS-CoV-2; - The United States Food and Drug Administration’s (USFDA) general recommendations and procedures applicable to the authorization of the emergency use of certain medical products under sections 564, 564A, and 564B of the Federal Food, Drug, and Cosmetic Act; - The decisions taken based on the Canada’s Minister of Health interim order (IO) to expedite the review of these medical devices, including test kits used to diagnose COVID-19; - The COVID-19 diagnostic tests approved by the Therapeutic Goods Administration (TGA) for inclusion on the Australian Register of Therapeutic Goods (ARTG) on the basis of the Expedited TGA assessment - The COVID-19 diagnostic tests approved by the Ministry of Health, Labour and Welfare after March 2020 with prior scientific review by the PMDA The following websites provide access to Instructions For Use of certain products: - https://www.who.int/diagnostics_laboratory/EUL/en/ - https://www.fda.gov/medical-devices/emergency-situations-medical-devices/emergency-use-authorizations Platform (Extraction and amplification equipement) List of SARS-CoV-2 Diagnostic test kits eligible for procurement according to Board Decision GF/B42/EDP11 1/20
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444213 1COPY COVID-19 QPCR KIT1DROP INC. (imported by Luminarie Canada
Inc.)
E gene and RdRp gene
100T/kit see IFU lower than -20 ºC see IFU
List of SARS-CoV-2 Diagnostic test kits and equipments eligible for procurement according to Board Decision on Additional Support for Country Responses to COVID-19 (GF/B42/EDP11)
The following emergency procedures established by WHO and the Regulatory Authorities of the Founding Members of the GHTF have been identified by the QA Team and will be used to determine eligibility for procurement of COVID-19 diagnostics. The product, to be considered as eligible for procurement with GF resources, shall be listed in one of the below mentioned lists:- WHO Prequalification decisions made as per the Emergency Use Listing (EUL) procedure opened to candidate in vitro diagnostics (IVDs) to detect SARS-CoV-2; - The United States Food and Drug Administration’s (USFDA) general recommendations and procedures applicable to the authorization of the emergency use of certain medical products under sections 564, 564A, and 564B of the Federal Food, Drug, and Cosmetic Act; - The decisions taken based on the Canada’s Minister of Health interim order (IO) to expedite the review of these medical devices, including test kits used to diagnose COVID-19;- The COVID-19 diagnostic tests approved by the Therapeutic Goods Administration (TGA) for inclusion on the Australian Register of Therapeutic Goods (ARTG) on the basis of the Expedited TGA assessment- The COVID-19 diagnostic tests approved by the Ministry of Health, Labour and Welfare after March 2020 with prior scientific review by the PMDA
The following websites provide access to Instructions For Use of certain products:- https://www.who.int/diagnostics_laboratory/EUL/en/- https://www.fda.gov/medical-devices/emergency-situations-medical-devices/emergency-use-authorizations
Platform (Extraction and amplification equipement)
List of SARS-CoV-2 Diagnostic test kits eligible for procurement according to
Platform (Extraction and amplification equipement)
MagMAX™ Viral/Pathogen
Nucleic Acid Isolation Kit
automated on KingFisher™ Flex
Purification System (KingFisher)
Bio-Rad CFX96 Touch Real-Time PCR
Detection System
MagMAX™ Viral/Pathogen
Nucleic Acid Isolation Kit
manual (KingFisher)
Applied Biosystems™ QuantStudio 5 Real-
Time PCR Instrument
Disclaimer:The Global Fund does not endorse or warrant the fitness of any product on the List for a particular purpose. In addition, the Global Fund assumes no responsibility for any misstatement or omission from the list and directs Principal Recipients of Global Fund grants to conduct their own independent confirmation that the information on a given product on the list is accurate before relying on it to make a purchase order for that product, and to ensure that any purchase is in compliance with all the requirements of the Global Fund’s quality assurance policy. The Global Fund does not warrant or represent that the products listed have obtained regulatory approval for use in any particular
country of the world, or that their use is otherwise in accordance with the national laws and regulations of any country, including, but not limited to, intellectual property laws. The Global Fund disclaims any and all liability and responsibility for any injury, death, damage or loss of any kind whatsoever that may arise as a result of, or in connection with the procurement, distribution and use of any product included in the list.
N/A- NOT APPLICABLE
US FDA EUAHealth Canada/Interim Order
TGAR3011
Quick SARS-CoV-2 rRT-PCR Kit
Zymo Research Corp N genes see IFU see IFU see IFU
For consumables and details of
componants refer to IFU
List of SARS-CoV-2 Diagnostic test kits eligible for procurement according to
Board Decision GF/B42/EDP1116/20
Version 52020-06-12
Manufacturer Product Catalogue number
Product Name(IVD product)
Number of tests per kit
Manufacturer AnalyteAnticipated
Shelf life (months)
Recommended storage temperature
Specimen type CommentsEligibility
WHO EUL or others
NOVA Test® COVID-19 IgG/IgM Antibody Test
(Colloidal Gold)see IFU n/a n/a
Atlaslink Beijing Technology Co Ltd
(China)IgG/IgM see IFU see IFU see IFU TGA
WJ-2701, WJ-2710, WJ-2750
Wantai SARS-CoV-2 Ab Rapid Test kit
see IFU n/a n/a
Beijing Wantai Biologicalpharmacy Enterprise Co Ltd
(China)
IgG/IgM see IFU see IFU see IFU TGA
5515C025 25
5515C050 50
5515C100 100
65-9569-0DPP® COVID-19 IgM/IgG
System20 see IFU
DPP Micro Reader or DPP Micro Reader 2
Chembio(USA)
IgG/IgM see IFU 2 to 30°C
serum, plasma
(EDTA or citrate), or
venipuncture wholeblood
US FDA EUA
65-9569-0DPP® COVID-19 IgM/IgG
System20 see IFU
DPP Micro Reader or DPP Micro Reader 2
Chembio(USA)
IgG/IgM see IFU 2 to 30°C
serum, plasma
(EDTA or citrate), or
venipuncture wholeblood
US FDA EUA
n/a n/aCellex Inc
(United States of America)
IgG/IgM
serum, plasma
(EDTA or citrate), or
venipuncture wholeblood
qSARS-CoV-2 IgG/IgM Rapid Test
2 to 30°C12US FDA EUA
TGA
List of SARS-CoV-2 Diagnostic test kits and equipments eligible for procurement according to Board Decision on Additional Support for Country Responses to COVID-19 (GF/B42/EDP11)
SARS-CoV-2 Rapid Diagnostic Tests
Important Precautionary statements:With the limited data now available, WHO does not currently recommend the use of antigen-detecting rapid diagnostic tests for patient care, although research into their performance and potential diagnostic utility is highly encouraged.
Based on current data, WHO does not recommend the use of antibody-detecting rapid diagnostic tests for patient care but encourages the continuation of work to establish their usefulness in disease surveillance and epidemiologic research. (https://www.who.int/news-room/commentaries/detail/advice-on-the-use-of-point-of-care-immunodiagnostic-tests-for-covid-19)
Platform (Calibrator and Equipment)
List of SARS-CoV-2 Diagnostic test kits eligible for procurement according to
Board Decision GF/B42/EDP1117/20
Manufacturer Product Catalogue number
Product Name(IVD product)
Number of tests per kit
Manufacturer AnalyteAnticipated
Shelf life (months)
Recommended storage temperature
Specimen type CommentsEligibility
WHO EUL or others
SARS-CoV-2 Rapid Diagnostic Tests
Platform (Calibrator and Equipment)
OnSite COVID-19 IgG/IgM Rapid Test
see IFU n/a n/a CTK Biotech Inc (USA) IgG/IgM see IFU see IFU see IFU TGA
GenBody COVID-19 IgM/IgG see IFU n/a n/aGenBody Inc (Korea -
Republic of)IgG/IgM see IFU see IFU see IFU TGA
SARS-CoV-2 Antibody Test (Lateral Flow Method)
see IFU n/a n/aGuangzhou Wondfo
Biotech Co Ltd (China)IgG/IgM see IFU see IFU see IFU TGA
W195SARS-CoV-2 Antibody Test
(Lateral Flow Method)see IFU n/a n/a
Guanngzhou Wondfo Biotech Co Ltd (China)
IgG/IgM see IFU see IFU see IFU TGA
INCP-4022019-n-CoV IgG/IgM Rapid
Test Cassettesee IFU n/a n/a
Hangzhou Alltest Biotech Co Ltd (China)
IgG/IgM see IFU see IFU see IFU TGA
COVID-19 IgG/IgM Rapid Test Cassette
see IFU n/a n/aHangzhou Biotest
Biotech Co Ltd (China)IgG/IgM see IFU see IFU see IFU TGA
RightSign™ COVID-19
IgG/IgM Rapid Test Cassettesee IFU n/a n/a
Hangzhou Biotest Biotech Co Ltd (China)
IgG/IgM see IFU see IFU see IFU US FDA EUA
Novel Coronavirus (2019-nCoV) IgM/IgG Antibody Combo Test Kit (Colloidal
Gold)
see IFU n/a n/aHangzhou Laihe
Biotech Co Ltd (China)IgG/IgM see IFU see IFU see IFU TGA
List of SARS-CoV-2 Diagnostic test kits eligible for procurement according to
Board Decision GF/B42/EDP1118/20
Manufacturer Product Catalogue number
Product Name(IVD product)
Number of tests per kit
Manufacturer AnalyteAnticipated
Shelf life (months)
Recommended storage temperature
Specimen type CommentsEligibility
WHO EUL or others
SARS-CoV-2 Rapid Diagnostic Tests
Platform (Calibrator and Equipment)
2019-nCOV/COVID-19 IgG/IgM Rapid Test Device
see IFU n/a n/aHangzhou Realy Tech
Co Ltd (China)IgG/IgM see IFU see IFU see IFU TGA
GCCOV-402aCOVID-19 IgG/IgM Rapid Test
Cassette25 n/a n/a
Healgen Scientific Limited Liability Company (United States Of America)
IgG/IgM see IFU see IFU see IFU
Testing is limited to laboratories
certified under the Clinical Laboratory
ImprovementAmendments of 1988 (CLIA), 42 U.S.C 263a, to
perform moderate or high
complexity tests
US FDA EUATGA
InnoScreenTM COVID-19 IgG/IgM Rapid Test
see IFU n/a n/a Innovation Scientific
Pty Ltd (Australia)IgG/IgM see IFU see IFU see IFU TGA
2019-nCov Ab Test (Colloidal Gold)
see IFU n/a n/aInnovita (Tangshan)
Biological Technology Co Ltd (China)
IgG/IgM see IFU see IFU see IFU TGA
COVID-19 IgG/IgM Rapid Test Kit
see IFU n/a n/aNantong Egens
Biotechnology Co Ltd (China)
IgG/IgM see IFU see IFU see IFU TGA
NTBIO One Step Rapid Test - COVID-19 IgG/IgM Antibody
Testsee IFU n/a n/a
NTBIO Diagnostics Inc (Canada)
IgG/IgM see IFU see IFU see IFU TGA
List of SARS-CoV-2 Diagnostic test kits eligible for procurement according to
Board Decision GF/B42/EDP1119/20
Manufacturer Product Catalogue number
Product Name(IVD product)
Number of tests per kit
Manufacturer AnalyteAnticipated
Shelf life (months)
Recommended storage temperature
Specimen type CommentsEligibility
WHO EUL or others
SARS-CoV-2 Rapid Diagnostic Tests
Platform (Calibrator and Equipment)
PCL COVID19 IgG/IgM Rapid Gold
see IFU n/a n/aPCL Inc (Korea -
Republic of)IgG/IgM see IFU see IFU see IFU TGA
SARS-CoV-2 IgM/lgG Antibody Rapid Test
see IFU n/a n/aQingdao Hightop
Biotech Co Ltd (China)IgG/IgM see IFU see IFU see IFU TGA
SARS-CoV-2 IgM/lgG Antibody Rapid Test
see IFU n/a n/aQingdao Hightop
Biotech Co Ltd (China)IgG/IgM see IFU see IFU see IFU TGA
VivaDiag™ COVID-19 IgM/IgG Rapid Test
see IFU n/a n/aVivaCheck Biotech (Hangzhou) Co Ltd
(China)IgG/IgM see IFU see IFU see IFU TGA
SARS-CoV-2 IgM/IgG Antibody Test Kit
see IFU n/a n/aWuhan EasyDiagnosis
Biomedicine Co Ltd (China)
IgG/IgM see IFU see IFU see IFU TGA
GCCOV-402a
COVID-19 IgG/IgM Rapid Test Cassette
see IFU n/a n/aZhejiang Orient Gene
Biotech Co Ltd (China)IgG/IgM see IFU see IFU see IFU TGA
Diagnostic Kit for IgM/IgG Antibody to Coronavirus
(SARS-CoV-2) (Lateral Flow)see IFU n/a n/a
Zhuhai Livzon Diagnostics Inc
(China)IgG/IgM see IFU see IFU see IFU TGA
N/A- NOT APPLICABLE
Disclaimer:The Global Fund does not endorse or warrant the fitness of any product on the List for a particular purpose. In addition, the Global Fund assumes no responsibility for any misstatement or omission from the list and directs Principal Recipients of Global Fund grants to conduct their own independent confirmation that the information on a given product on the list is accurate before relying on it to make a purchase order for that product, and to ensure that any purchase is in compliance with all the requirements of the Global Fund’s quality assurance policy. The Global Fund does not warrant or represent that the products listed have obtained regulatory approval for use in any particular
country of the world, or that their use is otherwise in accordance with the national laws and regulations of any country, including, but not limited to, intellectual property laws. The Global Fund disclaims any and all liability and responsibility for any injury, death, damage or loss of any kind whatsoever that may arise as a result of, or in connection with the procurement, distribution and use of any product included in the list.
List of SARS-CoV-2 Diagnostic test kits eligible for procurement according to